Invokana 300mg Film-Coated Tablets

Země: Malajsie

Jazyk: angličtina

Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivní složka:

Canagliflozin hemihydrate

Dostupné s:

JOHNSON & JOHNSON SDN BHD

INN (Mezinárodní Name):

Canagliflozin hemihydrate

Jednotky v balení:

30tablet Tablets

Výrobce:

JANSSEN CILAG SPA

Informace pro uživatele

INVOKANA
® FILM-COATED TABLETS
Canagliflozin (100mg & 300mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What INVOKANA
®
is used for
2.
How INVOKANA
®
works
3.
Before you use INVOKANA
®
4.
How to use INVOKANA
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
INVOKANA
®
8.
Product description
9.
Manufacturer and product registration
holder
10.
Date of revision
11.
Serial number
WHAT INVOKANA
®
IS USED FOR
INVOKANA
®
contains the active
substance canagliflozin. This belongs to a
group of medicines called “oral
antihyperglycemics.” INVOKANA
®
may
also be known as a diabetes medicine.
INVOKANA
®
is used to lower blood
sugar levels in adults with type 2 diabetes.
INVOKANA
®
can be used alone or
together with other medicines that your
doctor may prescribe to lower blood sugar.
It is also important to keep following your
doctor’s advice about diet and exercise.
_ _
If you have type 2 diabetes and an
increased cardiovascular risk (health
problems due to your heart and blood
vessels), INVOKANA
®
can be used along
with diet and exercise to lower your risk of
dying from events related to your heart or
blood vessels, and to lower your risk from
having non-fatal heart attacks and non-
fatal strokes.
INVOKANA
®
is used for type 2 diabetes
due to diabetic condition. This is when
your kidneys are damaged as a result of
your diabetes. INVOKANA
®
can be used
to slow down the progression rate of your
kidney disease and may also reduce death
rate relating to cardiovascular disease.
_ _
_What is type 2 diabetes? _
Type 2 diabetes is a condition in which
your body does not make enough insulin,
and the insulin that your body produces
does not work as well as it should. Your
body can also make too much sugar. When
this happens, sugar (glucose) builds up in
the blood. This can lead to serious medical
conditions such as heart disease, kidney
disease, blindness, and amputation.
HOW INVOKANA
® WORKS
INVOKANA
®
works by increasing the
amount of sugar removed from t

Charakteristika produktu

1
1.
NAME OF THE MEDICINAL PRODUCT
Invokana
®
100 mg film-coated tablets
Invokana
®
300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Invokana 100 mg film-coated tablets
Each tablet contains canagliflozin hemihydrate, equivalent to 100 mg
canagliflozin.
_Excipient(s) with known effect _
Each tablet contains 39.2 mg lactose.
Invokana 300 mg film-coated tablets
Each tablet contains canagliflozin hemihydrate, equivalent to 300 mg
canagliflozin.
_Excipient(s) with known effect _
Each tablet contains 117.78 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Invokana 100 mg film-coated tablets
The tablet is yellow, capsule-shaped, approximately 11 mm in length,
immediate-release and
film-coated, with “CFZ” on one side and “100” on the other
side.
Invokana 300 mg film-coated tablets
The tablet is white, capsule-shaped, approximately 17 mm in length,
immediate-release and
film-coated, with “CFZ” on one side and “300” on the other
side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Monotherapy
INVOKANA (canagliflozin) is indicated as an adjunct to diet and
exercise to improve glycemic control in
adult patients with type 2 diabetes mellitus for whom metformin is
inappropriate due to contraindications
or intolerance.
_ _
Combination with Metformin or a Sulfonylurea
INVOKANA is indicated in combination with metformin or a sulfonylurea
in adult patients with type 2
diabetes mellitus to improve glycemic control when diet and exercise
plus monotherapy with one of these
agents does not provide adequate glycemic control.
Combination with Metformin and either a Sulfonylurea or Pioglitazone
INVOKANA is indicated in combination with metformin and either a
sulfonylurea or pioglitazone in adult
patients with type 2 diabetes mellitus to improve glycemic control
when diet, exercise, and dual therapy
(with metformin plus either a sulfonylurea or pioglitazone) do not
provide adequate glycemic control.
Combination with Insulin
INVOKA